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Women should not use Vyleesi if they have high blood pressure that is not controlled (uncontrolled hypertension) or known heart (cardiovascular) disease.

Vyleesi is not for the treatment of HSDD in women who have gone through menopause or in men.
Vyleesi is not for use to improve sexual performance. Vyleesi is not for use in children.

Before using Vyleesi, tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if Vyleesi will harm your unborn baby. Women who can become pregnant should use effective birth control during treatment with Vyleesi.

Patients should avoid using Vyleesi with an orally administered naltrexone-containing product intended to treat alcohol and opioid addiction, due to the severe consequence of naltrexone treatment failure.

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